FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
K Number: K120245
·
Decision Jun 21, 2012
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
83
Applicant Total
20
Review Days
146
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Basic Information
- Device Name
- PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
- K Number
- K120245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5460
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Playtex, Inc.
- Date Received
- January 27, 2012
- Decision Date
- June 21, 2012
- Product Code
- HIL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.
ONTEX AND OTHERS PROPRIETARY NAMES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Playtex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980478 | PLAYTEX TAMPONS #03498 | Apr 3, 1998 | Substantially Equivalent |
| K971174 | PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS | May 21, 1997 | Substantially Equivalent |
| K944064 | PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 | Feb 9, 1995 | Substantially Equivalent |
| K941044 | PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 | Jul 27, 1994 | Substantially Equivalent |
| K942418 | PLAYTEX TAMPONS MODEL 13794 | Jul 8, 1994 | Substantially Equivalent |
| K881057 | PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER | Mar 22, 1988 | Substantially Equivalent |
| K874509 | PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL | Jan 7, 1988 | Substantially Equivalent |
| K843551 | PLAYTEX BABY POWDER DEODORANT TAMPONS | Dec 3, 1984 | Substantially Equivalent |
| K841154 | PLAYTEX SLENDER REGULAR TAMPONS | Mar 19, 1984 | Unknown |
| K841155 | DEODORANT SLENDER REG. TAMPONS | Mar 19, 1984 | Unknown |